At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Post-operative, Stereotactic Body Radiation Therapy (SBRT)radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 18, 2012·Updated Jun 25, 2020
In Brief
A Phase 2 clinical trial evaluating Post-operative, Stereotactic Body Radiation Therapy (SBRT) for Solid Tumor Spine Metastases. Completed, enrolled 35 participants across 1 site.
Detailed Summary
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor Spine Metastases
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartMay 2013
Primary CompletionApr 2018
Study CompletionJul 2018
TodayJul 2026
First PostedDec 18, 2012
Enrollment StartMay 20, 2013
Primary CompletionApr 2, 2018
Study CompletionJul 27, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.5 years ago
Interventions
Post-operative, Stereotactic Body Radiation Therapy (SBRT)radiation
All participants received SBRT at 600 cGy x 5 fractions